Patent refusals on the ground of lack of inventive step must be supported by clear and consistent reasoning, especially in cases where the Controller records a technical difference between the claimed invention and the cited prior art. If the order acknowledges a difference or advantage in the claimed invention, the conclusion must explain why that distinction is still insufficient to meet the inventive step requirement. The Madras High Court found a patent refusal order to be arbitrary while dealing with the rejection of Elanco US Inc.’s patent application in the appeal Elanco US Inc vs Assistant Controller of Patents and Designs [CMA(PT) No. 37 of 2024].
Factual Matrix
Elanco US Inc.’s patent application No. 201948050412 for an oral pharmaceutical composition for treating chronic inappetence and chronic weight loss in a companion animal was rejected by the respondent Controller vide order dated May 20, 2024. The application was rejected on the ground that the claimed invention lacked inventive step in view of prior art D1. Elanco preferred an appeal, which was decided by the Madras High Court on July 14, 2026.
Courts Analysis and Findings
The Court observed that the appellant’s patent application had been rejected on the ground that the claimed invention was substantially the same as disclosed in prior art D1. However, on analysis of the impugned order, the Court found that the order itself recorded a difference between the claimed invention and the closest prior art. The prior art did not provide safety data on the maximum dose of the drug for continued use, whereas the drug sought to be patented was recorded as having no adverse clinical side effects on companion animals.
Court’s Ruling and Directions
The Court noted that the respondent Controller had acknowledged that the claimed invention differed from D1 in relation to safety data on the maximum dose for continued use and had also recorded that the drug had no adverse clinical side effects on companion animals. The Court found that, having recorded such reasoning in favour of the claimed invention, the rejection simpliciter on the ground of lack of inventive step could not be sustained. Therefore, the Court held that the refusal “is smacked by arbitrariness”.
The Court set aside the impugned order and directed that the application be reconsidered by an officer other than the officer who had issued the impugned order, in order to preclude the possibility of pre-determination. The Court further directed that, after providing a reasonable opportunity to the appellant, a reasoned decision be issued within 4 months from the date of receipt of a copy of the order.
Conclusion
The decision highlights that an order for patent refusal must be consistent and supported by clear reasoning. In cases where the Controller’s analysis records a technical difference or advantage, the order must explain why such difference was insufficient to establish an inventive step.
Author: DPS Parmar